Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI) (RemPostCon)
This study has been completed.
Sponsor:
IRCCS Policlinico S. Matteo
Information provided by (Responsible Party):
Maurizio Ferrario, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT00865722
First received: March 18, 2009
Last updated: August 16, 2012
Last verified: August 2012
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Purpose
Background: Experimental studies suggest that remote limb ischaemic postconditioning (RemPostCon) can reduce infarct size in pigs. Initial clinical applications support the beneficial role of RemPostCon in preserving endothelial function during upper limb ischemia in healthy volunteers and in patients with stable coronary artery disease.
Aim of the study: To evaluate the feasibility, safety and efficacy of RemPostCon in the setting of STEMI and primary PCI (pPCI) and to investigate potential circulating mediators of its effects.
Patients and methods: Patients who undergo pPCI for anterior STEMI within 6 hours since the onset of symptoms are randomly assigned to receive either RemPostCon + pPCI or pPCI alone in a single-blind fashion. All patients receive therapy according to the current international guidelines. Three cycles of ischemia-reperfusion are provided to the lower limb inflating a cuff to 200 mmHg. Each cycle consists of 5' of ischaemia, followed by 5' of reperfusion. RemPostCon is started at the time of angioplasty in the infarct related artery. Primary endpoint is the area under the curve (AUC) of creatinine kinase - MB (CK - MB). Cardiac magnetic resonance (CMR) is performed early before discharge and 4 months after the event, if there are no contraindications.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Reperfusion Injury Myocardial Ischemia Myocardial Infarction |
Procedure: Remote Postconditioning |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pilot Study to Test Feasibility, Safety, Molecular Mediators and Preliminary Efficacy of Remote Myocardial Postconditioning Provided With Extrinsic Cuff Compression of Lower Limb During Primary PCI |
Resource links provided by NLM:
Further study details as provided by IRCCS Policlinico S. Matteo:
Primary Outcome Measures:
- Area Under the Curve of CK - MB release [ Time Frame: baseline to 72h since admission ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Area Under the Curve of CK release [ Time Frame: baselinte to 72h since admission ] [ Designated as safety issue: No ]
- TIMI Frame Count [ Time Frame: 30 minutes after first balloon inflation in infarct-related artery ] [ Designated as safety issue: No ]
- Time to balloon [ Time Frame: during pPCI ] [ Designated as safety issue: Yes ]
- Ejection Fraction MRI [ Time Frame: before discharge and after 4 months ] [ Designated as safety issue: No ]
- Myocardial Blush grading [ Time Frame: 30 minutes after first balloon inflation ] [ Designated as safety issue: No ]
- ST segment resolution [ Time Frame: 6h after balloon ] [ Designated as safety issue: No ]
- Troponin I peak [ Time Frame: 72h since admission ] [ Designated as safety issue: No ]
- Mortality rate [ Time Frame: 4 months since admission ] [ Designated as safety issue: Yes ]
- artero-venous differences in pO2, pCO2, pH, HCo3 [ Time Frame: baseline and 30 minutes after first balloon inflation ] [ Designated as safety issue: No ]
- Major adverse cardiac events [ Time Frame: 4 months since admission ] [ Designated as safety issue: Yes ]
- artero-venous quantitative and qualitative differences in endothelial progenitors cells (subgroups) [ Time Frame: within 24 h since admission ] [ Designated as safety issue: No ]
- artero-venous Differences of Cytokines [ Time Frame: within 24h since admission ] [ Designated as safety issue: No ]
- Edema Volume T2 sequences MRI [ Time Frame: before discharge ] [ Designated as safety issue: No ]
- Delay enhancement volume MRI [ Time Frame: before discharge and after 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | March 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: RemotePostConditioning
Patients will receive pPCI and treatments according to guidelines for STEMI PLUS extrinsic cuff compression to the lower limb for 5 ' followed by 5' reperfusion for three cycles (30' in total) starting with myocardial reperfusion
|
Procedure: Remote Postconditioning
Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'
|
|
Sham Comparator: Controls
pPCI and treatments according to guidelines for STEMI
|
Procedure: Remote Postconditioning
Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age >= 18 yrs AND Age =< 80 yrs
- STEMI definition
- Pain to door time < 6 hrs
- Killip class 1 - 2 - 3
- Initial TIMI flow 0 - 1 in the anterior descending artery
- Signed informed consent
Exclusion Criteria:
- Pregnancy
- Cardiogenic shock
- Initial TIMI flow 2 - 3 in the anterior descending artery
- History of prior MI in the past 6 months
- History of prior CABG
- History of peripheral vascular disease III - IV grade
- History of abdominal Aortic Aneurysm > 5 cm
- Severe coronaropathy that could condition further revascularization before the end of the study
- Other relevant medical or surgical conditions that can influence prognosis at 4 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865722
Locations
| Italy | |
| ASL3 Genovese, Villa Scassi Hospitale | |
| Genoa, Italy, 16100 | |
| IRCCS Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
| Study Director: | Maurizio Ferrario, MD | IRCCS Policlinico San Matteo |
| Principal Investigator: | Gabriele Crimi, MD | IRCCS Policlinico San Matteo |
More Information
No publications provided
| Responsible Party: | Maurizio Ferrario, MD, IRCCS Policlinico S. Matteo |
| ClinicalTrials.gov Identifier: | NCT00865722 History of Changes |
| Other Study ID Numbers: | RemPostConditioning |
| Study First Received: | March 18, 2009 |
| Last Updated: | August 16, 2012 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by IRCCS Policlinico S. Matteo:
|
Remote Postconditioning Myocardial reperfusion Injury Myocardial Infarction Primary PCI |
Additional relevant MeSH terms:
|
Myocardial Ischemia Coronary Artery Disease Infarction Ischemia Myocardial Infarction Myocardial Reperfusion Injury Reperfusion Injury Heart Diseases Cardiovascular Diseases |
Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes Necrosis Cardiomyopathies Postoperative Complications |
ClinicalTrials.gov processed this record on May 23, 2013